RectiCare Complete Hemorrhoid Care System
Drug Labeling and Warnings
Drug Details [pdf]
RECTICARE COMPLETE- lidocaine and phenylephrine hcl and glycerin and mineral oil and white petrolatum
Ferndale Laboratories, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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RectiCare Complete Hemorrhoid Care System
RECTICARE ADVANCED HEMORRHOIDAL CREAM
Active ingredients
Lidocaine 5% w/w
Mineral Oil 17% w/w
Phenylephrine HCl 0.25% w/w
White Petrolatum 39% w/w
Purpose
Lidocaine 5% w/w................................Local anesthetic
Mineral Oil 17% w/w............................Protectant
Phenylephrine HCl 0.25% w/w.............Vasoconstrictor
White Petrolatum 39% w/w.................Protectant
Uses
- helps relieve the pain, itching and burning associated with hemorrhoids
- temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects irritated areas and inflamed perianal skin
Warnings
For external use only.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
When using this product
- avoid contact with eyes
- do not exceed recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Directions
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
- adults and children 12 years and older: apply externally to the affected area up to 4 times daily
- children under 12 years of age: consult a doctor
- To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
Other information
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]
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RECTICARE ADVANCED HEMORRHOIDAL WIPES
Active ingredients
Glycerin 20% w/w
Lidocaine 5% w/w
Phenylephrine HCL 0.25% w/w
Purpose
Glycerin 20% w/w..................................Protectant
Lidocaine 5% w/w.................................Local anesthetic
Phenylephrine HCL 0.25% w/w.............Vasoconstrictor
Uses
- helps relieve the pain, itching and burning associated with hemorrhoids
- temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects irritated areas and inflamed perianal skin
Warnings
For external use only.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
When using this product
- avoid contact with eyes
- do not exceed recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Directions
- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
- Gently apply wipe to the affected area by patting and then discard.
- adults and children 12 years and older: apply externally to the affected area up to 4 times daily
- children under 12 years of age: consult a doctor
| RECTICARE COMPLETE
lidocaine and phenylephrine hcl and glycerin and mineral oil and white petrolatum kit |
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| Labeler - Ferndale Laboratories, Inc. (005320536) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ferndale Laboratories, Inc. | 005320536 | manufacture(0496-0985, 0496-0978, 0496-0979) | |
Revised: 10/2019
Document Id: 946783a7-500f-84d5-e053-2995a90a13f9
Set id: 64d33e62-5048-4d3c-9095-84397a8d3fa4
Version: 2
Effective Time: 20191008